Patient SafetyQUALI-IINCT04800796
Transfer of Standard Operating Procedures in Anesthesiology
An observational study of Patient Safety, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Safety
- What is being tested?
- Audiovisual
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2021to 7 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: anesthesia physicians who participating in a Scenario training
Who may be able to join
- anesthesia residents
- anesthesia consultants
Who cannot join
- nurses
- students
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Evaluation From Didactic and Structural Transfer of Standard Operating Procedures in Anesthesiology
Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications.
Read the detailed description
The Primary endpoint is the comparison of a Intervention Group with audiovisually blended learning concept and a Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.
- Conditions
- Patient Safety
- Being tested
- Audiovisual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AudiovisualOther
Receive blended learning before and reading the Standard operating procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Intervention Group with audiovisually blended learning concept Receives: Other: Audiovisual | |
| Standard group | Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SOP deviations
SOP deviations during scenario training
Measured: 12 minutes after start scenario
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2021
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, PhD, Principal investigator, University JG, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800796
- Sponsor's protocol ID
- JohannesGUQ
- Acronym
- QUALI-II
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation From Didactic and Structural Transfer of Standard Operating Procedures in Anesthesiology
- ClinicalTrials.gov ID
- NCT04800796
- Acronym / sponsor ID
- QUALI-II / JohannesGUQ
- Conditions
- Patient Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients safety and high Quality Performance built up the centre of anesthesiology. Standard operating procedures based on the Helsinki declaration may help to increase the Patient safety and decreased adverse Events or complications.
Detailed description
The Primary endpoint is the comparison of a Intervention Group with audiovisually blended learning concept and a Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: AudiovisualIntervention Group with audiovisually blended learning concept |
| Standard group | – | –Standard Group receiving the Standard operating procedures via E-Mail and Confirmation when reading. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- anesthesia physicians who participating in a Scenario training
Key inclusion criteria (2 listed)
- anesthesia residents
- anesthesia consultants
Key exclusion criteria (2 listed)
- nurses
- students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AudiovisualReceive blended learning before and reading the Standard operating procedure | Other | Intervention Group |
Primary outcome
Rate of SOP deviations
Time frame: 12 minutes after start scenario
SOP deviations during scenario training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Kriege, MD, PhD principal investigator
University JG, Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of SOP deviations (time frame: 12 minutes after start scenario). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.